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NCT02893436 Clinical Trial

Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

Surgery Clinical Trial

— DBS PREDICTION  

Official title:
Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02893436
Other study ID # PSS2014/DBSPREDICTION-SCHMARTZ
Secondary ID
Status Recruiting
Phase N/A
First received August 31, 2016
Last updated September 2, 2016
Start date April 2014
Est. completion date September 2016

Study information
Verified date August 2016
Source Central Hospital, Nancy, France
Contact Denis Schmartz
Email d.schmartz@chru-nancu.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.

Description:

Neuromuscular monitoring is a basic monitoring for all curarised patients. Acceleromiography is used to supervise neuromuscular blockade and allow measuring in an objective and quantitative manner the curarisation level during surgery and phase of recovery from neuromuscular blockade. Various parameters are usually measured during surgery:

- T4/T1 ratio: ratio between the 4th and 1st response to "train of four" stimulation (TOF, 4 stimulations of 0.2 ms in 2 s). Neuromuscular recovery is considered appropriate if T4/T1 ratio is > 0.9

- Double burst stimulation (DBS): 2 short tetanic stimulations separated by an interval of 750 ms.

It is known that when DBSs induce the same visual and/or tactile response, T4/T1 recovery time is > 0.6. However, for an optimal recovery, T4/T1 ratio must be > 0.9.

This study will analyze the interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9, from anesthesia sheet of patients undergone surgery with tracheal intubation curarisation.

Results will define a minimum time to have an optimal recovery after having visually identical DBS responses.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ASA score 1-3

- Needing a surgery with tracheal intubation curarisation

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgery with tracheal intubation curarisation

Locations
Country Name City State
France CHRU Nancy Vandoeuvre Les Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time interval between the moment when DBSs are visually identical and the T4/T1 ratio is > 0.9 measured with TOF-Watch Sx day 0 No
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